(10 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the pediatric head and spine, that can be interpreted by a trained physician.
Model PHSL-63-SYM and PHS-63-SYM Pediatric Head and Spine Array Coils
The provided text does not contain information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device's performance. The document is a 510(k) clearance letter from the FDA for pediatric head and spine array coils, affirming their substantial equivalence to predicate devices and detailing regulatory information. It does not include a performance study.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.